Contactless skin scanners for blood flow in type 1 diabetes
Tests two contactless optical devices measuring skin blood flow in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: The MIND Study - Microangiopathy IN Diabetes
Key facts
- Where
- Stockholm, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06989190, who can take part
Where in Sweden
- VO Medicinska Specialiteter, Danderyd HospitalStockholm, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HJN Sverige AB/Neko Health
- Trial code
- NCT06989190
- Record updated
- 25 May 2025
- Original description
This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.Read full original descriptionShow less
The MIND Study - Microangiopathy IN Diabetes
This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.
Inclusion: Severe type 1 diabetes (microangiopathy / diabetic feet), severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers; Age range: primarily 18-45 years, if not sufficient number of subjects can be found, then 18-60 years span is considered; Phase 2: Scale of severity. In phase 2, patients are included with a broad range of severity levels. Patients with diabetes type 1 will be included; Age range: 18-45 years (younger patients are targeted for focus on microvascular complications, rather than age-related cardiovascular disease); Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a), 100 patients; Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy (group b), 100 patients; Patient with moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c), 50 patients; Healthy controls:; Healthy control matched to the type 1 diabetes patients in age and gender, with no known risk of increased cardiovascular disease.
Exclusion: Patients unable to understand patient information due to cognitive impairment; Ongoing acute infection or inflammatory condition; Patients unable to understand patient information due to language barriers; Pregnant or breastfeeding women; Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices.
Phase 1: Severe Diabetic Complications (50 patients).